FDA 510(k)

VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

K-Number: K123930 · 2013-05-15

ApplicantOrtho-Clinical Diagnostics, Inc.

Decision Date2013-05-15

Product CodeLPS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-05-15 under 510(k) number K123930. The device is classified under product code LPS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III?

VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III is a medical device that received FDA 510(k) clearance on 2013-05-15. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K123930.

When did VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III received FDA 510(k) clearance on 2013-05-15, under 510(k) number K123930.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III?

The FDA product code for VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III is LPS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.